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临床试验/NCT02030223
NCT02030223已完成不适用

The Analgesic Efficacy of the Ultrasound Guided Transversus Abdominis Plane Block After Inguinal Hernia Repair With a Mesh.

Papacharalampous Panagiota1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
1
主要终点
Pain scores at rest and with movement using the numerical rating scale (NRS)

研究概览

简要总结

This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III patients undergoing inguinal hernia repair with a mesh
  • age between 18 and 75 years old
  • ability to read and write greek

排除标准

  • Inability to consent to the study
  • BMI >40kg/m2
  • Skin infection at the puncture site
  • Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
  • Preoperative use of opioids or NSAID's for chronic pain conditions

研究组 & 干预措施

Transversus abdominis plane block with 20 ml ropivacaine 0,75%

Active Comparator

Transversus abdominis plane block with 20 ml ropivacaine 0,75%

干预措施: Transversus abdominis plane block (Procedure)

Transversus abdominis plane block with 20 ml saline

Placebo Comparator

Transversus abdominis plane block with 20 ml saline

干预措施: Transversus abdominis plane block (Procedure)

结局指标

主要结局

Pain scores at rest and with movement using the numerical rating scale (NRS)

时间窗: 3, 6 and 24 hours postoperatively

次要结局

  • Incidence of chronic pain(6 months after surgery)

研究者

发起方
Papacharalampous Panagiota
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Papacharalampous Panagiota

Anesthesiologist

Aretaieion University Hospital

研究点 (1)

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